FDA.reportPublic FDA data

NDC 61958-1102 - COMPLERA Access

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61958-1102
Package NDCs from labels
61958-1102-5
Manufacturer
Gilead Sciences, Inc.
Effective date
2025-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COMPLERA Access - Gilead Sciences, Inc.Gilead Sciences, Inc.2025-07-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-1102-52024-09-25C16284748780-1ab0e2407-349c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA™ (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2011
61958-1102-52024-07-30C16284748780-1ab0e2407-349c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA™ (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2011
61958-1102-32020-07-22C16284748780-1ab0e2407-349c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA™ (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1102-5COMPLERA Access30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1102COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]91 package rows20240927_9176bf31-c889-47bd-861c-f2d3fc37ab8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EMTRICITABINEACTIVE INGREDIENTG70B4ETF4SCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
RILPIVIRINE HYDROCHLORIDEACTIVE INGREDIENT212WAX8KDDCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TENOFOVIR DISOPROXIL FUMARATEACTIVE INGREDIENTOTT9J7900ICOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
EMTRICITABINEACTIVE MOIETYG70B4ETF4SCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
RILPIVIRINEACTIVE MOIETYFI96A8X663COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TENOFOVIR ANHYDROUSACTIVE MOIETYW4HFE001U5COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 118 · 2,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.